The International journal of risk & safety in medicine最新文献

{"title":"SSRI antidepressants and perceived loss of lean muscle in men: A qualitative exploration of some online anecdotal concerns.","authors":"Nicholas Norman Adams","doi":"10.1177/09246479251346445","DOIUrl":"10.1177/09246479251346445","url":null,"abstract":"<p><p>BackgroundThis study examines anecdotal reports from online discussion forums suggesting possible links between SSRI antidepressants and loss of lean muscle mass, particularly in men. Given limited existing scientific research, this study bolsters academic discourse.ObjectiveDo self-reported experiences from internet forums indicate a perceived connection between SSRI use and muscle mass reductions?MethodA Google keyword search identified 202 posts from 14 randomly selected online antidepressant discussion forums. Posts were collected and thematically analysed.ResultsForum users reported difficulties in maintaining or gaining lean muscle after commencing SSRI treatment. Key themes included frustration, confusion, and attempts to rationalise perceived changes.ConclusionFindings suggest an area for further exploration, regarding the physiological impact of SSRIs on muscle composition. While reports remain anecdotal, they highlight concerns immediately relevant to both patients and healthcare professionals. As the study is based on self-reported experiences from anonymous sources, findings lack scientific validation but highlight requirements for further studies to explore prevalence and broader applicability. Research observations spotlight a need for further, structured clinical research to investigate possible effects of SSRIs on muscle mass.Future research should include controlled clinical trials and longitudinal studies to examine a potential association in more detail.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"208-217"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12552761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144129747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Restoring TADS: RIAT reanalysis of the Treatment for Adolescents with Depression Study.","authors":"Natalie Aboustate, Jon Jureidini, Richard Woodman, Joanna Le Noury, Julie Klau, Elia Abi-Jaoude, Melissa Raven","doi":"10.1177/09246479251337879","DOIUrl":"10.1177/09246479251337879","url":null,"abstract":"<p><p>BackgroundThe Treatment for Adolescents with Depression Study (TADS) continues to influence international clinical practice guidelines for adolescent depression.ObjectiveWe assessed TADS' effectiveness and harms through a Restoring Invisible and Abandoned Trials (RIAT)-led reanalysis.MethodsTADS was a phase-three multicentre, parallel four-arm randomised controlled superiority trial that randomised adolescents (<i>n</i> = 439) to fluoxetine alone (FLX), CBT alone (CBT), open-label fluoxetine plus CBT (COMB) or placebo pill alone (PBO) over 12 weeks. COMB and CBT groups were unblinded to their treatment allocation. Primary outcomes were the Children's Depression Rating Scale-Revised (CDRS-R) and Clinical Global Impression-Improvement scale (CGI-I).ResultsOur ITT reanalysis showed a significant decrease in CDRS-R at 12 weeks in COMB compared with PBO (-6.65; <i>p</i> < 0.001) and CBT (-7.63, <i>p</i> < 0.001), but not FLX (-4.07, <i>p</i> = 0.063). There was no difference between FLX, CBT and PBO. There was a higher proportion of CGI-I responders in COMB (73.72% [SE 4.43]) compared with all other arms: FLX (64.16% [SE 4.76]), CBT (51.06% [SE 5.29]) and PBO (38.76% [SE 4.87]; all <i>p</i> < 0.001); FLX had more responders than PBO (<i>p</i> = 0.004). 369 adverse events were reported for 171 participants, with 66% occurring in those taking fluoxetine. We found 32 serious adverse events (22 in those taking fluoxetine), which varied from original authors' reporting.ConclusionsOur reanalysis replicated the original investigators' reporting that COMB demonstrated the most robust outcomes and that FLX was not superior to PBO. In contrast to the original TADS Team's reporting, there was a higher level of harm uncovered in allocation groups taking fluoxetine, including 11 unreported suicide-related adverse events. Overall, the marked increase in harms among participants taking fluoxetine warrants further circumspection when prescribing it to adolescents.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"218-237"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12552760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144153211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perceptions of occupational exposure and adherence to safety measures of handling systemic anti-cancer therapy (SACT) among oncology nurses at the national cancer institute, Sri Lanka.","authors":"Nsasn Senarath, D De Silva, Rwmwk Rathnayake, Ssp Warnakulasuriya, Mkdl Meegoda, S S Jayasinghe","doi":"10.1177/09246479251346172","DOIUrl":"10.1177/09246479251346172","url":null,"abstract":"<p><p>BackgroundChemotherapy is a well-known treatment modality against cancer. Occupational exposure to chemotherapy and related adverse effects are widely reported. Safe handling is vital in the reduction of possible risks.ObjectiveTo assess perceptions of occupational exposure and adherence to safety measures of handling Systemic Anti-Cancer Therapy (SACT) among nurses.MethodsA phenomenological study was carried out using a semi-structured, in-depth interviewer guide following the Health Belief Model (HBM) components. The study adopted a purposive sampling method, and data was collected until it reached the saturation point. A thematic analysis was carried out, preserving the study's trustworthiness.ResultsThe nurse's main role was to administer chemotherapy. The primary learning sources were clinical experience and follow-up with seniors. Nurses accept that they are occupationally exposed to chemotherapy and believe that safety measures are protective against exposure. Surgical gloves and masks were common PPE, and chemotherapy-specific masks and gowns were mainly used in mixing drugs. Staffing, safe work practices, separate waste disposal, and seniors' guidance are identified as protective measures. Headache, vomiting, hair loss, skin irritation, and miscarriages were commonly perceived as adverse effects of handling SACT.ConclusionsAn increased patient count, frequent complex doses, a lack of PPE and facilities, and discomfort with PPE might increase exposure.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"248-259"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144201365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid review of drug induced Stevens Johnson Syndrome case reports from 2003 to 2023: Trends among monoclonal antibodies and systemic immunosuppressant therapy.","authors":"Maxine Gossell-Williams, Gabrielle McLaren, Rojay Clarke, Shenae Douglas, Devonne Gayle, Kerrian Guthrie","doi":"10.1177/09246479251368022","DOIUrl":"10.1177/09246479251368022","url":null,"abstract":"<p><p>BackgroundDrug-induced Steven-Johnson Syndrome (SJS) is a life-threatening hypersensitivity reaction and systemic steroid immunosuppressant therapy is not universally recommended. With the changing landscape of new drugs, it is important to determine emerging trends in this severe drug induced adverse event.ObjectiveThe objectives were to examine drug induced SJS case reports published from January 1 2003 to December 31 2023 for emerging trends of drugs implicated and systemic immunosuppressant therapy administered.MethodsLiterature search was done using PubMed (MEDLINE) database with keywords and Boolean terms, \"Stevens Johnson Syndrome\" AND \"Case Report,\" filtered for the time period of interest, articles available free and in English. Included case reports were only studies in which a single drug was implicated.ResultsForty-nine case reports met inclusion criteria and critical analysis of quality rated studies from moderate to strong; however, causality assessment instrument was only reported for 10 (20%) case reports. There was equal distribution by sex; patient ages ranged from 2 to 95 years and 34 (69.4%) case reports originated from countries of the Asian continent. Most common drug implicated was carbamazepine, 5 (10.2%); pembrolizumab was implicated in 4 of 9 case reports involving monoclonal antibody drugs. Thirty-seven patients (75.5%) received systemic steroid immunosuppressant therapy. Two patients (4.1%) died during the clinical course.ConclusionThe published case reports are predominately from countries known to be at higher risk of drug induced SJS and the emerging greater number of case reports implicating pembrolizumab may be an important safety concern, needing further investigation. Systemic steroid use was the preferred immunosuppressant therapy.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"156-167"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144802488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From reaction to reporting: Impact of pharmacovigilance in a tertiary care hospital setting at Belagavi.","authors":"Pratiksha Kini, Mandati Santhosh Reddy, M S Ganachari","doi":"10.1177/09246479251364713","DOIUrl":"10.1177/09246479251364713","url":null,"abstract":"<p><p>BackgroundAdverse drug reactions (ADRs) pose significant risks to patient safety, particularly in tertiary care settings characterized by polypharmacy and multiple comorbidities. Monitoring and evaluating ADRs is vital to improving therapeutic outcomes and minimizing harm.ObjectiveThis study aimed to assess the pattern, severity, predictability, seriousness, and causality of ADRs reported in a tertiary care teaching hospital in Belagavi, India.MethodsA prospective observational study was conducted on 2035 spontaneously reported ADRs collected between January and December 2024 at the Adverse Drug Reaction Monitoring Centre under the Pharmacovigilance Programme of India (PvPI). Data were analyzed using the WHO-UMC causality assessment, Hartwig and Siegel severity scale, and standard classifications for seriousness and predictability.ResultsAdults (60.54%) and elderly (24.67%) were most frequently affected. Gastrointestinal disorders (23.91%) were the most commonly reported System Organ Class (SOC). Most ADRs were predictable (87.81%) and probable in causality (67.91%). Severe ADRs accounted for 15.97%. Vomiting and headache were the most reported adverse events. Antiretroviral were the most commonly implicated drug class.ConclusionThe majority of ADRs were predictable and involved widely used drug classes. Strengthening pharmacovigilance practices and implementing targeted clinical interventions are essential to prevent avoidable ADRs and improve patient safety.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"281-288"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144736686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance: Overview of Italian and European regulations, tools, and perspectives.","authors":"Eleonora Castellana, Patricia Madalina Budau, Maria Rachele Chiappetta","doi":"10.1177/09246479251366836","DOIUrl":"10.1177/09246479251366836","url":null,"abstract":"<p><p>BackgroundThis study provides a concise overview of the Italian and European pharmacovigilance (PV) systems.ObjectiveTo evaluate the regulatory frameworks of above mentioned systems, operational tools, and recent trends in adverse drug reaction (ADR) reporting. The primary objective is to highlight the strengths and critical issues of the current system in improving drug safety and protecting public health.MethodsOur analysis confirms a progressive increase in ADR reporting in Italy over the past decade, with a peak in 2021 during the COVID-19 vaccination campaign, followed by a subsequent decline.ResultsHospital physicians and pharmacists remain the primary reporters, while patient reports account for around 10%. The causality assessment process continues to rely heavily on tools such as the Naranjo algorithm and the WHO-UMC criteria, although no single gold standard exists. Despite regulatory improvements and digital infrastructure development, key limitations persist, notably underreporting, inconsistent report quality, and lack of population exposure data.ConclusionWhile Italy's PV system has evolved considerably, a more integrated, proactive, and technology-enhanced approach is required to improve the sensitivity and timeliness of signal detection. Future directions should include the use of artificial intelligence, electronic health records, and real-world evidence to enhance pharmacovigilance performance.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"147-155"},"PeriodicalIF":0.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144796636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Research evidence for health education in patient safety and research-informed health policy decision-making.","authors":"Liliya Eugenevna Ziganshina","doi":"10.1177/09246479251359481","DOIUrl":"10.1177/09246479251359481","url":null,"abstract":"","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"101-102"},"PeriodicalIF":0.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144652010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trend analysis of adverse drug reactions to sedative-hypnotics among residents in Jiangsu Province of China, 2011-2019.","authors":"Jinxia Yu, Ming Li, Hui Xue, Yitao Liu, Lijun Fan, Jianjun Zou, Wei Du","doi":"10.1177/09246479251360682","DOIUrl":"10.1177/09246479251360682","url":null,"abstract":"<p><p>BackgroundThe safety of sedative-hypnotic drugs represents an underrecognized and crucial public health concern, despite their widespread use.ObjectiveThe objective of this study was to investigate the characteristics and trends of adverse drug reactions (ADRs) to sedative-hypnotics in China.MethodData were extracted from the spontaneous reporting system (SRS) for ADR surveillance in Jiangsu Province. Sedative-hypnotic drugs for ADRs were coded using the Anatomical Therapeutic Chemical classification system. We used the Chinese modification of the International Classification of Diseases, Tenth Revision, to group primary diseases, and the Medical Dictionary for Regulatory Activities to classify the manifestation of ADRs. We analysed the characteristics of ADR reports, including demographic and sedative-hypnotics information, ADR involvement of system organs and clinical manifestations, and cost of ADRs. Joinpoint regression was employed to estimate age-adjusted ADR rates stratified by sex from 2011 to 2019, and the percentage change annualized estimator was used to evaluate trends over time.ResultsA total of 899 reports of ADRs to sedative-hypnotics were found, with 440 (49.1%) males and 459 (50.9%) females. Regarding ADRs to sedative-hypnotics, neurological disorders (310 cases, 34.5%) were the most common. An estimated cost savings of RMB 6031.98-54,287.82 (USD 826.38-7437.43) could be realised if 10%-90% of the ADRs in this study were reduced. The age-adjusted ADRs reporting rates increased significantly from 0.06 to 0.18 per 100,000 population during 2011-2019, representing an annual increase of 14.5% (95% confidence interval 9.4-19.9%; <i>p</i>-value < 0.001). There was a gender difference, with an age-adjusted ADRs annual increase of 14.0% (95% confidence interval 6.6%-21.9%; <i>p</i>-value 0.002) for males and 14.8% (95% confidence interval 7.5%-22.6%; <i>p</i>-value 0.002) for females.ConclusionsReports of sedative-hypnotic ADRs were on the rise during the study period, and there was a gender difference. More rational policies and systems are needed to promote the safe use of sedative-hypnotic drugs.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479251360682"},"PeriodicalIF":0.8,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144661774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Approach to the management of COVID-19 patients: When home care can represent the best practice.","authors":"Gerardo Tricarico,&nbsp;Valter Travagli","doi":"10.3233/JRS-210064","DOIUrl":"https://doi.org/10.3233/JRS-210064","url":null,"abstract":"<p><strong>Background: </strong>The pandemic that began around February 2020, caused by the viral pathogen SARS-CoV-2 (COVID-19), has still not completed its course at present in June 2022.</p><p><strong>Objective: </strong>The open research to date highlights just how varied and complex the outcome of the contagion can be.</p><p><strong>Method: </strong>The clinical pictures observed following the contagion present variabilities that cannot be explained completely by the patient's age (which, with the new variants, is rapidly changing, increasingly affecting younger patients) nor by symptoms and concomitant pathologies (which are no longer proving to be decisive in recent cases) in relation to medium-to-long term sequelae. In particular, the functions of the vascular endothelium and vascular lesions at the pre-capillary level represent the source of tissue hypoxia and other damage, resulting in the clinical evolution of COVID-19.</p><p><strong>Results: </strong>Keeping the patient at home with targeted therapeutic support, aimed at not worsening vascular endothelium damage with early and appropriate stimulation of endothelial cells, ameliorates the glycocalyx function and improves the prognosis and, in some circumstances, could be the best practice suitable for certain patients.</p><p><strong>Conclusion: </strong>Clinical information thus far collected may be of immense value in developing a better understanding of the present pandemic and future occurrences regarding patient safety, pharmaceutical care and therapy liability.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"249-259"},"PeriodicalIF":1.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40479514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Restoring the two pivotal fluoxetine trials in children and adolescents with depression.","authors":"Peter C Gøtzsche,&nbsp;David Healy","doi":"10.3233/JRS-210034","DOIUrl":"https://doi.org/10.3233/JRS-210034","url":null,"abstract":"<p><strong>Background: </strong>Fluoxetine was approved for depression in children and adolescents based on two placebo-controlled trials, X065 and HCJE, with 96 and 219 participants, respectively.</p><p><strong>Objective: </strong>To review these trials, which appear to have been misreported.</p><p><strong>Methods: </strong>Systematic review of the clinical study reports and publications. The primary outcomes were the efficacy variables in the trial protocols, suicidal events, and precursors to suicidality or violence.</p><p><strong>Results: </strong>Essential information was missing and there were unexplained numerical inconsistencies. (1) The efficacy outcomes were biased in favour of fluoxetine by differential dropouts and missing data. The efficacy on the Children's Depression Rating Scale-Revised was 4% of the baseline score, which is not clinically relevant. Patient ratings did not find fluoxetine effective. (2) Suicidal events were missing in the publications and the study reports. Precursors to suicidality or violence occurred more often on fluoxetine than on placebo. For trial HCJE, the number needed to harm was 6 for nervous system events, 7 for moderate or severe harm, and 10 for severe harm. Fluoxetine reduced height and weight over 19 weeks by 1.0 cm and 1.1 kg, respectively, and prolonged the QT interval.</p><p><strong>Conclusions: </strong>Our reanalysis of the two pivotal trials showed that fluoxetine is unsafe and ineffective.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"385-408"},"PeriodicalIF":1.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40479513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}